169 Auditor Compliance Associate QA CQA

169 QA CQA Auditor Compliance Associate (Job ID 169 QAA)

 

The successful candidate will work to ensure QA Quality Assurance compliance for a major global medical device company. YOU MUST HAVE A CQA DESIGNATION in order to qualify for this position.




Responsibilities

- Responsible for maintenance of pertinent standards including but not limited to: 21 CFR Part 820, ISO9001:2000, MDD, ISO13485:2003, Canadian Medical Device Regulation

- Write, revise, manage and review SOP from a QA perspective

 

- Using your expertise in QSR quality systems and quality techniques, perform/assist in internal assessments by collecting and analyzing accurate and objective evidence

 

- Using your  high level of expertise in current regulatory requirements and technical issues, participate in QA/QC multi-site projects in the roles to include contributor, coordinator or leader

 

- Assist in the training of staff and assure that physician and staff training requirements are met and records are up to date

 

- Use your knowledge of FDA Regulations, CAPA, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices to assure company stays in compliance with QSR
 

- Participate in FDA and ISO audits and QSR Regulatory Assurance as required
 

 

Educational Requirements 

BA/BS Degree in business, engineering, life science, engineering, quality or regulatory compliance or related areas

 

 





Required Experience

- 3++  years experience in Quality Assurance or QC/QA analysis



- Knowledge of FDA and ISO regulations regarding RA/QA regulations and knowledge of scientific strategies and new methods or new avenues of investigation

- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices 

- Excellent proven interpersonal skills in dealing with all levels of professionals

- Proficiency in the use of PC and programs, particularly Excel, Word

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